Opportunity Information: Apply for PAR 18 684
The NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required), PAR 18-684, is a National Institutes of Health grant opportunity designed to fund investigator-initiated phase I clinical trials focused on new diagnostic or therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in both adults and children. The central aim is to help move promising interventions into early human testing, with the expectation that applicants are proposing a study that meets the NIH definition of a clinical trial and clearly aligns with the NHLBI mission and research priorities. Trials may be conducted at a single site or across multiple sites, depending on what best fits the clinical question, recruitment needs, and operational realities of the project.
A defining feature of this opportunity is its bi-phasic, milestone-driven structure. In practice, that means the award is set up in two parts, with explicit performance benchmarks that must be met to progress. The first phase is intended to support critical pre-trial start-up activities that are often required before enrollment can begin, such as product stability work, shipping and handling studies, and training clinical sites so procedures are consistent and trial-ready. The second phase is where the clinical trial itself is carried out. Because the mechanism is milestone-based, applicants are expected to propose clear, measurable milestones tied to both scientific goals and operational deliverables, and to show they have a realistic plan to meet them.
Applications are expected to go beyond a basic study synopsis and instead provide a strong scientific rationale for why the intervention should be tested in humans at this stage, along with a detailed scientific and operational plan. That plan should cover how the trial will be managed day-to-day, how participants will be recruited and retained, how data and safety will be handled, what the key timelines and decision points are, and how results will be analyzed and disseminated. The FOA signals that NHLBI is looking for well-prepared teams that can execute an early phase trial responsibly, including attention to practical issues that can derail trials, like site readiness, participant enrollment challenges, and product logistics.
Team structure is an important emphasis. While not mandatory, the multiple PD/PI model is strongly encouraged, reflecting how early phase trials often require a blend of leadership across clinical expertise, trial operations, and product development. Applicants are encouraged to assemble teams with capabilities in biostatistics, clinical trial design, and trial coordination, as well as manufacturing and formulation expertise when relevant to the therapeutic or diagnostic being tested. Because of the complexity and regulatory considerations involved in conducting clinical trials, prospective applicants are strongly encouraged to contact the designated NHLBI scientific/research staff prior to submission. The intent is that NHLBI staff can help applicants interpret expectations, ensure alignment with the FOA, and troubleshoot common planning gaps before an application is finalized.
In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible organization types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based or community-based organizations and U.S. territories or possessions.
Foreign eligibility is more limited. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning parts of the work can be conducted outside the U.S. when appropriately justified and structured under a U.S. applicant organization.
From the funding details provided, this is a discretionary NIH grant in the health area (CFDA numbers listed include 93.233 and 93.837-93.839), with an award ceiling of $1,515,000. The opportunity was created on February 27, 2018, and the original closing date listed is January 7, 2021. Overall, the FOA is geared toward applicants who are ready to run a rigorously planned phase I trial and who can demonstrate both the scientific premise for testing the intervention and the operational readiness to carry out the study under a milestone-based award structure.Apply for PAR 18 684
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839.
- This funding opportunity was created on 2018-02-27.
- Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,515,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required), PAR 18-684
What is PAR 18-684?
PAR 18-684 is a National Institutes of Health (NIH) funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) that supports investigator-initiated early phase (phase I) clinical trials of new therapeutic and/or diagnostic interventions related to heart, lung, blood, and sleep (HLBS) disorders.
What is the main purpose of this grant opportunity?
The central goal is to help move promising therapeutics or diagnostics into early human testing by funding phase I clinical trials that meet the NIH definition of a clinical trial and clearly align with the NHLBI mission and research priorities.
What types of studies are expected under this opportunity?
Applications are expected to propose a study that meets the NIH definition of a clinical trial. The focus is on early human testing (phase I) of a therapeutic or diagnostic intervention relevant to HLBS disorders.
Is a clinical trial required for this FOA?
Yes. The opportunity is labeled "R33 Clinical Trial Required," and applicants are expected to propose a study that meets the NIH definition of a clinical trial.
What clinical trial phase does this FOA support?
This FOA is designed to support phase I clinical trials (early phase human testing).
What disease areas or conditions are in scope?
The scope includes heart, lung, blood, and sleep (HLBS) disorders.
Does the FOA support studies in both adults and children?
Yes. The FOA is intended to support phase I clinical trials in both adult and pediatric populations when appropriate to the proposed intervention and clinical question.
Are both therapeutic and diagnostic interventions eligible?
Yes. The FOA specifically supports early phase clinical trials focused on new diagnostic and/or therapeutic interventions.
Can the trial be conducted at a single site?
Yes. Trials may be conducted at a single site if that approach best fits the clinical question, recruitment needs, and the operational realities of the project.
Can the trial be conducted across multiple sites?
Yes. Multi-site trials are allowed when they are appropriate for the scientific question, recruitment requirements, and operational plan.
What is meant by a bi-phasic, milestone-driven structure?
The award is structured in two parts (two phases) with explicit performance benchmarks (milestones). Progression from the first phase to the second phase depends on meeting the proposed milestones tied to scientific and operational deliverables.
What happens in the first phase of the award?
The first phase supports key pre-trial start-up activities that often must be completed before participant enrollment begins. Examples provided include product stability work, shipping and handling studies, and training clinical sites so procedures are consistent and trial-ready.
What happens in the second phase of the award?
The second phase is when the clinical trial itself is conducted.
What kinds of milestones are expected in an application?
Applicants are expected to propose clear, measurable milestones linked to both scientific goals and operational deliverables, and to present a realistic plan for achieving them in order to progress through the milestone-based structure.
What level of detail is expected in the application?
The application is expected to go beyond a basic study synopsis. It should include a strong scientific rationale for testing the intervention in humans at this stage, along with a detailed scientific and operational plan for executing the trial.
What operational elements should the plan address?
Based on the FOA description, the plan should address day-to-day trial management, participant recruitment and retention, data handling, safety oversight, key timelines and decision points, and plans for analysis and dissemination of results.
What practical risks does NHLBI emphasize applicants should plan for?
The FOA highlights practical issues that can derail trials, including site readiness, participant enrollment challenges, and product logistics (such as stability and shipping/handling considerations).
Is the multiple PD/PI (multiple Principal Investigators) model required?
No. It is not mandatory, but it is strongly encouraged because early phase clinical trials often require shared leadership across clinical expertise, trial operations, and product development.
What kinds of expertise are applicants encouraged to include on the team?
The FOA encourages teams with capabilities in biostatistics, clinical trial design, and trial coordination. It also encourages manufacturing and formulation expertise when that is relevant to the therapeutic or diagnostic being tested.
Should applicants contact NHLBI staff before submitting?
Yes. Prospective applicants are strongly encouraged to contact the designated NHLBI scientific/research staff prior to submission to help interpret expectations, confirm alignment with the FOA, and address common planning gaps.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and governments. Examples listed include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and other entities.
Are minority-serving institutions and community-based organizations eligible?
Yes. The FOA explicitly highlights eligible organization types such as HBCUs, Hispanic-serving Institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, as well as faith-based or community-based organizations and U.S. territories or possessions.
Can a non-U.S. (foreign) organization apply as the main applicant?
No. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply as the applicant organization.
Can any part of the work be conducted outside the United States?
Yes, in limited ways. Non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning parts of the work may occur outside the U.S. when appropriately justified and structured under a U.S. applicant organization.
What is the maximum award amount mentioned?
The funding details provided list an award ceiling of $1,515,000.
What type of funding mechanism is this?
It is an NIH grant opportunity using an R33 mechanism with a milestone-driven, two-phase structure, and it is described as discretionary funding in the health area.
What CFDA numbers are associated with this opportunity?
The information provided lists CFDA numbers that include 93.233 and 93.837-93.839.
When was this opportunity created?
The opportunity was created on February 27, 2018.
What is the closing date listed in the provided information?
The original closing date listed is January 7, 2021.
What kind of applicant is this FOA geared toward?
It is geared toward applicants who are ready to run a rigorously planned phase I trial and who can demonstrate both the scientific premise for testing the intervention and the operational readiness to carry out the study under a milestone-based award structure.
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Applicants who have applied for this opportunity (PAR 18 684) also looked into and applied for these:
| Funding Opportunity |
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| NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required) Apply for PAR 18 683 Funding Number: PAR 18 683 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NINDS Postdoctoral Mentored Career Development Award (K01 No Independent Clinical Trial Allowed) Apply for PAR 18 686 Funding Number: PAR 18 686 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NINDS Postdoctoral Mentored Career Development Award (K01 Clinical Trial Required) Apply for PAR 18 685 Funding Number: PAR 18 685 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Limited Competition : HIV/AIDS-related Non-Human Primate Animal Research Facilities Restoration Program in the Aftermath of Hurricane Maria (C06 Clinical Trial Not Allowed) Apply for PAR 18 693 Funding Number: PAR 18 693 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| USAID/Kyrgyz Republic Tuberculosis (TB) Control Program Apply for RFI 72011519RFA00001 Funding Number: RFI 72011519RFA00001 Agency: Kazakhstan USAID-Almaty Category: Health Funding Amount: Case Dependent |
| Center without Walls for PET Ligand Development for Alzheimer's disease related dementias (ADRDs) (U19 Clinical Trial Optional) Apply for RFA NS 18 025 Funding Number: RFA NS 18 025 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Interdisciplinary Research Teams to Investigate Reciprocal Basic Behavioral and Social Linkages Between Sleep and Stress (R24 Clinical Trial Optional) Apply for PAR 18 694 Funding Number: PAR 18 694 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required) Apply for PAR 18 696 Funding Number: PAR 18 696 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Basic and Translational Oral Health Research Related to HIV/AIDS (R01 Clinical Trial Not Allowed) Apply for PA 18 699 Funding Number: PA 18 699 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional) Apply for PAR 18 701 Funding Number: PAR 18 701 Agency: National Institutes of Health Category: Health Funding Amount: $1,000,000 |
| Natural Product, Multi-Site, Clinical Trial, Data Coordinating Center (Collaborative U24 - Clinical Trial Required) Apply for PAR 18 697 Funding Number: PAR 18 697 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Stimulating T4 Implementation Research to Optimize Integration of Proven-effective Interventions for Heart, Lung, and Blood Diseases and Sleep Disorders into Practice (STIMULATE) (R01 Clinical Trial Not Allowed) Apply for RFA HL 19 014 Funding Number: RFA HL 19 014 Agency: National Institutes of Health Category: Health Funding Amount: $485,000 |
| Basic and Translational Oral Health Research Related to HIV/AIDS (R21 Clinical Trial Not Allowed) Apply for PA 18 695 Funding Number: PA 18 695 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| NIDCD Research Dissertation Fellowship for Au.D. Audiologists (F32) (Clinical Trials Not Allowed) Apply for PA 18 700 Funding Number: PA 18 700 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NEI Translational Research Program (TRP) on Therapy for Visual Disorders (R24 Clinical Trial Optional) Apply for PAR 18 707 Funding Number: PAR 18 707 Agency: National Institutes of Health Category: Health Funding Amount: $1,500,000 |
| Selective Cell and Network Vulnerability in Aging and Alzheimers Disease (R01 - Clinical Trial Not Allowed) Apply for PAR 18 706 Funding Number: PAR 18 706 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Autoimmunity Centers of Excellence, Basic Research Program (U19 Clinical Trial Not Allowed) Apply for RFA AI 18 002 Funding Number: RFA AI 18 002 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Autoimmunity Centers of Excellence, Clinical Research Program (UM1 Clinical Trial Required) Apply for RFA AI 18 003 Funding Number: RFA AI 18 003 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCD Research Dissertation Fellowship for Au.D. Audiologists (F32) (Clinical Trials Not Allowed) Apply for PAR 18 700 Funding Number: PAR 18 700 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed) Apply for PAR 18 714 Funding Number: PAR 18 714 Agency: National Institutes of Health Category: Health Funding Amount: $300,000 |
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